Mild to Moderate Bronchial Asthma Clinical Trial
Official title:
Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
| Verified date | January 2015 |
| Source | SamA Pharmaceutical Co., Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Interventional |
Clinical Study to Evaluate the Efficacy, Dose-response and Safety of SA09012 in Bronchial Asthma Patients
| Status | Completed |
| Enrollment | 225 |
| Est. completion date | November 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 79 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis or presence of asthma within 3 months of the prestudy visit 1. Increase in PEF = 20% or = 60L/min from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit 2. Increase in FEV1 = 12% and = 200mL from baseline value after taking Bronchodilator at screening or within the 3 months of the prestudy visit - FEV1 or PEF between 60% and 85% of the predicted value at screening or within the 3 months of the prestudy visit - Having signed an informed consent Exclusion Criteria: - Patient who has severe asthma - Patient who has any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study other protocol-defined inclusion/exclusion criteria may apply - Patient with an AST or ALT > 2x ULN (upper limit of normal) in the screening visit - Patient with more than 10 pack year of cigarettes history |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chonbuk National University Hospital | Chonbuk | |
| Korea, Republic of | Chungbuk National University Hospital | Chungbuk | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Ajou University Hospital | Gyeonggi | |
| Korea, Republic of | Bucheon St. Mary's Hospital, The Catholic University of Korea | Gyeonggi | |
| Korea, Republic of | Hallym University Sacred Heart Hospital | Gyeonggi | |
| Korea, Republic of | Soon Chun Hyang University Bucheon Hospital | Gyeonggi | |
| Korea, Republic of | Konkuk University Medical Center | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | KyungHee University Medical Center | Seoul | |
| Korea, Republic of | Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | |
| Korea, Republic of | Soonchunhyang University Hospital, Seoul | Seoul | |
| Korea, Republic of | St. Paul's Hospital, The Catholic University of Korea | Seoul | |
| Korea, Republic of | Yonsei University, Gangnam Severance Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| SamA Pharmaceutical Co., Ltd |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change from baseline of PEF(Peak Expiratory Flow)at week 6 | 6 week treatment period | No | |
| Secondary | Mean change from baseline in FEV1 at week 6 | 6 week treatment period | No | |
| Secondary | Mean change from baseline in ACT(Asthma Control Test) at week 6 | 6 week treatment period | No | |
| Secondary | Safety assessment(Comparison of the adverse event profiles throughout the course of the study) | 6 week treatment period | Yes |